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CorPath® GRX Neuro Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236856
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Corindus Inc.

Tracking Information
First Submitted Date  ICMJE January 2, 2020
First Posted Date  ICMJE January 22, 2020
Last Update Posted Date January 22, 2020
Estimated Study Start Date  ICMJE March 2020
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
  • Procedural Technical Success. [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    The primary effectiveness endpoint will be defined as successful completion of the robotic-assisted endovascular procedure absent any unplanned conversion to manual for guidewire or microcatheter navigation, embolization coil(s) or intracranial stent(s) deployment, or an inability to navigate vessel anatomy.
  • Incidence of Inta- and Peri-procedural Events. [ Time Frame: Measured from the start of the procedure through 24 hours or discharge. ]
    The primary safety endpoint will be a composite of intra- and periprocedural events, including target aneurysmal rupture, vessel perforation or dissection, and thromboembolic event with neurological decline within 24-hours post- procedure or hospital discharge, whichever occurs first.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2020)
  • Robotically Navigate Device to the Target Aneurysm [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    Defined as successful advancement of device to the target aneurysm robotically.
  • Robotically Navigate Device into the Target Aneurysm [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    Defined as successful navigation of device into the target aneurysm robotically
  • Robotically Deploy Therapeutic Device into the Target Aneurysm [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    Defined as successful deployment of therapeutic device into the target aneurysm robotically
  • Overall Procedure Time [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    Defined as the time measured from the insertion of the access sheath/catheter until the removal of the microcatheter
  • Fluoroscopy Time [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    Total fluoroscopy utilized during the procedure as recorded by the Imaging System
  • Patient Radiation Exposure [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    DAP (dose-area-product) and/or AK (Air Kerma) as recorded during the procedure
  • Contrast Fluid Volume [ Time Frame: Measured from the start of the procedure to the end of the procedure. ]
    Total contrast used during the procedure
  • Adverse Events [ Time Frame: Measured from the start of the procedure through 24 hours or discharge. ]
    All adverse events (AEs) from the start of the CorPath GRX procedure until the end of the study will be summarized;
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CorPath® GRX Neuro Study
Official Title  ICMJE An Evaluation of Effectiveness and Safety of the CorPath® GRX System in Endovascular Embolization Procedures of Cerebral Aneurysms
Brief Summary The primary objective of this study is to evaluate the effectiveness and safety of robotic-assisted endovascular embolization procedures compared to objective performance criteria for traditional, manual operation based on the scientific literature.
Detailed Description This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls. Subject selection requires a clinical indication for endovascular coil and/or stent-assist coiling embolization of cerebral aneurysms.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
This is a prospective, single-arm, international, multi- center, non-inferiority study to evaluate the effectiveness and safety of the CorPath GRX System for endovascular cerebral aneurysm embolization compared to historical controls.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Intracranial Aneurysm
  • Subarachnoid Hemorrhage
  • Headache
Intervention  ICMJE Device: Robotic Endovascular Procedure
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
Other Name: CorPath GRX System
Study Arms  ICMJE Robotic Endovascular Procedure
Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.
Intervention: Device: Robotic Endovascular Procedure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 20, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. At least one cerebral aneurysm (unruptured or ruptured) with indication for endovascular treatment; dome to neck ratio>1.5;
  3. The Investigator deems the procedure appropriate for robotic-assisted endovascular treatment;
  4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

  1. Failure/inability/unwillingness to provide informed consent.
  2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tina M Ridgeway, BS, RN 7578105166 tina.ridgeway@corindus.com
Contact: John Van Vleet 2066158892 john.vanvleet@corindus.com
Listed Location Countries  ICMJE France,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04236856
Other Study ID Numbers  ICMJE 104-08660
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share IPD.
Responsible Party Corindus Inc.
Study Sponsor  ICMJE Corindus Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel Piotin, MD, PhD Interventional Neuroradiologisit & Director, Foundation Rothschild
PRS Account Corindus Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP